The CARENET all-comer trial using the CGuard micronet covered carotid embolic prevention stent

Transcription

1 The CARENET all-comer trial using the CGuard micronet covered carotid embolic prevention stent 6 month data Piotr Musialek, MD DPhil FESC Jagiellonian University Dept. of Cardiac & Vascular Diseases John Paul II Hospital, Krakow, Poland

2 The CARENET all-comer trial using the CGuard micronet-covered carotid embolic prevention stent 6 month data Piotr Musialek, MD DPhil FESC Jagiellonian University Dept. of Cardiac & Vascular Diseases John Paul II Hospital, Krakow, Poland

3 The CARENET all-comer trial using the CGuard micronet-covered carotid embolic prevention stent 6 month data Piotr Musialek, MD DPhil FESC Jagiellonian University Dept. of Cardiac & Vascular Diseases John Paul II Hospital, Krakow, Poland

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5 CAS: State-of-the-art and horizon

6 CAS (and CEA) are and will remain emboli-generating procedures

7 n = 3179 consecutive CAS patients 2/3 CAS neuro events (stroke, TIA) are POST-procedural

8 FREE CELL AREA drives CAS neurologic adverse events ( and majority are those during stent healing! )

9 conventional best-in-class Hybrid stent ( open-close-open ) conventional best-in-class Closed-cell stent P Musialek, LINC

10 K. Mathias, TCT 2013 J. Schofer, P. Musialek et al. TCT 2014

11 ANY data on incidence of PLAQUE PROLAPSE in conventional carotid stents? P Musialek, LINC

12 Post-procedural PLAQUE PROLAPSE through conventional stent struts 30.7% 1/3 stents = Precise 2/3 stents = Carotid Wallstent Suzuki M et al. ESC 2014 Eur Heart J. 2014;35(Abstr Suppl):178

13 Post-procedural PLAQUE PROLAPSE through conventional stent struts Suzuki M et al. ESC 2014 Presentation % 1/3 stents = Precise 2/3 stents = Carotid Wallstent Images: Dr M. Suzuki ESC Eur Heart J. 2014;35(Abstr Suppl):178

14 DW-MRI: the unforgiving testimony of what you ve done to the TARGET ORGAN... P Musialek, LINC

15 The Power of DW-MRI cm³ cm³ 48h after LICA-CAS M. Urbanczyk, P. Banys, Dept. Radiology, JP2 Hospital, Krakow, Poland

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17 CGuard embolic prevention stent P Musialek, LINC

18 CGuard Carotid Embolic Prevention System System specifications Stent type Nitinol self expanding Micronet aperture size m Guidewire Sizes - Diameter - Length 6-10mm 20-60mm

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20 CARENET Study Design Study Design: Prospective, multi-center, single arm, all-comer Objectives: To evaluate the periprocedural safety and efficacy of the CGuard stent in the treatment of carotid lesions in thirty consecutive patients with symptomatic and asymptomatic. carotid artery stenosis, suitable for CAS Sites: Joachim Schofer, Hamburg University Cardiovascular Center. Piotr Musialek, Jagiellonian University Medical College Ralf Kolvenbach, Augusta Hospital Horst Sievert, Cardiovascular Center Frankfurt Primary Endpoint: 30 day MACCE (death, stroke, MI)

21 CARENET Baseline Characteristics Baseline characteristics CARENET (n=30) Age (years) 71.6 ±7.6 Male 63.4% Symptomatic 33.3 (10) BMI 26.4 ±3.9 Hypertension 83.3% (25) Hyperlipidemia 90% (27) Diabetes mellitus 23.3% (7) Cigarette smoking, current 13.4% (4) Prior myocardial infarction 26.7% (8) J. Schofer, P. Musialek et al. (manuscript at review)

22 CARENET Procedure Results Target vessel - Left ICA - Right ICA Protection used -Distal filter protection -Proximal balloon protection 33.3% (10) 66.6% (20) 96.6% (29) 3.4% (1) Pre dilatation 70.9% (22) Post dilatation 77.4% (24) Post dilatation Pressure (ATM) 13.6 ±4.5 Stent deployed 100% (30) Procedure success 100% (30) Stent diameter (Mean) 8.23mm ± 0.8 Stent length (Mean) 34.8 mm ± 5.0 Second stent used 3.33% (1) J. Schofer, P. Musialek et al. (manuscript at review)

23 CARENET Procedure Results Angiographic assessment, CARENET (n=30) Baseline Final Lesion location in left/right ICA 33/67% - Lesion length [mm] 16.94±4.7 - MLD [mm] 1.25± ±0.60 % Diameter stenosis 79.9± ±6.5 TIMI III flow in the ECA 100% 100% J. Schofer, P. Musialek et al. (manuscript at review)

24 CARENET Clinical Events 30 days (n=30) 6 months (n=28*) MACCE (MI, stroke, death) (0) 0.0% (1) 3.6% MI (0) 0.0% (0) 0.0% stroke (0) 0.0% (0) 0.0% death (0) 0.0% (1) 3.6% J. Schofer, P. Musialek et al. (manuscript at review)

25 CARENET Clinical Events 30 days (n=30) 6 months (n=28*) MACCE (MI, stroke, death) (0) 0.0% (1) 3.6% MI (0) 0.0% (0) 0.0% stroke (0) 0.0% (0) 0.0% death (0) 0.0% (1) 3.6% * see patient fluxogram J. Schofer, P. Musialek et al. (manuscript at review)

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27 DW-MRI: the unforgiving testimony of what you ve done to the TARGET ORGAN... P Musialek, LINC

28 CGuard embolic prevention stent P Musialek, LINC

29 DWI Flair CARENET PJ, (Krakow) Baseline Prior to CAS 24h after CAS LICA 30 days after CAS DWI No new CAS-related lesions No new lesions between 24h and 30d Flair External, blinded CoreLab MRI image analysis and quantification (USA)

30 CARENET DW-MRI analysis * DW-MRI 48 hours CARENET (n=27) PROFI (all) (n=62) ICSS (n=56) Incidence of new ipsilateral lesions 37.0% 66.2% 68.0% Average lesion volume (cm 3 ) ± Maximum lesion volume (cm 3 ) see patient fluxogram *External Core Lab analysis (US) Bijuklic et al. JACC, 2012; Bonati et. al, Lancet Neurol 2010 bilateral lesions J. Schofer, P. Musialek et al. (manuscript at review)

31 CARENET DW-MRI analysis * DW-MRI 48 hours CARENET (n=27) PROFI (all) (n=62) ICSS (n=56) Incidence of new ipsilateral lesions 37.0% 66.2% 68.0% Average lesion volume (cm 3 ) ± Maximum lesion volume (cm 3 ) see patient fluxogram *External Core Lab analysis (US) Bijuklic et al. JACC, 2012; Bonati et. al, Lancet Neurol 2010 bilateral lesions J. Schofer, P. Musialek et al. (manuscript at review)

32 CARENET DW-MRI analysis * DW-MRI 48 hours CARENET (n=27) PROFI (all) (n=62) ICSS (n=56) Incidence of new ipsilateral lesions 37.0% 66.2% 68.0% Average lesion volume (cm 3 ) ± Maximum lesion volume (cm 3 ) % reduction in new ipsilateral lesion incidence *External Core Lab analysis (US) Bijuklic et al. JACC, 2012; Bonati et. al, Lancet Neurol 2010 bilateral lesions J. Schofer, P. Musialek et al. (manuscript at review)

33 CARENET DW-MRI analysis * DW-MRI 48 hours CARENET (n=27) PROFI (all) (n=62) ICSS (n=56) Incidence of new ipsilateral lesions 37.0% 66.2% 68.0% Average lesion volume (cm 3 ) Maximum lesion volume (cm 3 ) *External Core Lab analysis (US) Bijuklic et al. JACC, 2012; Bonati et. al, Lancet Neurol 2010 bilateral lesions J. Schofer, P. Musialek et al. (manuscript at review)

34 CARENET DW-MRI analysis * DW-MRI 48 hours CARENET (n=27) PROFI (all) (n=62) ICSS (n=56) Incidence of new ipsilateral lesions 37.0% 66.2% 68.0% Average lesion volume (cm 3 ) Maximum lesion volume (cm 3 ) >10-fold reduction in cerebral lesion volume *External Core Lab analysis (US) Bijuklic et al. JACC, 2012; Bonati et. al, Lancet Neurol 2010 bilateral lesions J. Schofer, P. Musialek et al. (manuscript at review)

35 CARENET DW-MRI analysis DW-MRI 48 hours CARENET (n=27) PROFI (all) (n=62) ICSS (n=56) Incidence of new ipsilateral lesions 37.0% 66.2% 68.0% Average lesion volume (cm 3 ) ± Maximum lesion volume (cm 3 ) Bijuklic et al. JACC, 2012; Bonati et. al, Lancet Neurol 2010 bilateral lesions

36 CARENET DW-MRI analysis DW-MRI 48 hours CARENET (n=27) PROFI (all) (n=62) ICSS (n=56) Incidence of new ipsilateral lesions 37.0% 66.2% 68.0% Average lesion volume (cm 3 ) ± Maximum lesion volume (cm 3 ) ICSS Bijuklic et al. JACC, 2012; Bonati et. al, Lancet Neurol 2010 bilateral lesions

37 * see patient fluxogram Bijuklic et al. JACC, 2012;59 CARENET: DW-MRI analysis DW-MRI 48 hours*

38 incidence new ipsilateral lesions (%) * See patient fluxogram Bijuklic et al. JACC, 2012;59 volume ipsilateral lesions (cm 3 ) CARENET vs. PROFI DW-MRI 48 hours* CARENET (distal and proximal) CARENET (distal only) 0,6 0, ,1 0,5 70 0, , , ,6 0,2 20 0,1 0, E-16 0,039 0,04

39 CARENET: 30-day DW-MRI analysis All but one peri-procedural ipsilateral lesions RESOLVED * *External Core Lab analysis (US) J. Schofer, P. Musialek et al. (manuscript at review)

40 CARENET: 30-day DW-MRI analysis All but one peri-procedural ipsilateral lesions RESOLVED * DW-MRI 30 days* Incidence of new ipsilateral lesions 1 Average lesion volume (cm 3 ) 0.08 ± 0.00 Permanent lesions at 30 days 1 *External Core Lab analysis (US) * see patient fluxogram J. Schofer, P. Musialek et al. (manuscript at review)

41 CGuard: Long-term Stent Evaluation. Routine Duplex Doppler ultrasound at discharge, 30 days, 6 and 12 months and then yearly. (Intravascular ultrasound). (CT angiography) J. Schofer, P. Musialek et al. (manuscript at review)

42 CARENET in-stent Peak Systolic Velocities >70% in-stent stenosis threshold* >50% in-stent stenosis threshold* 30 day 6 months NB. in one patient 6 mo ultrasound data pending (NB. ECA patency * Setacci et. al, Grading Carotid Intrastent Restenosis of 814 CAS patients Stroke. 2008

43 Initial series of IVUS CGuard TM studies suggests.... Excellent stent expansion and apposition ZERO tissue protrusion though mesh-and-struts Piotr LINC

44 5 months follow-up CGuard Piotr LINC

45 RCCA & RICA LICA CGuard 5 months follow-up Wallstent Precise Piotr LINC

46 CGuard: Endovascular Solution For All-comers 61 yo symptomatic LICA 72 yo asymptomatic RICA Piotr LINC

47 CAS (and CEA) are and will remain emboli-generating procedures Stent placement amenable to elimination with mesh Stent relaese P LINC

48 CAS: 2010 Vision

49 CGuard embolic prevention stent system Compatible with ALL EPD types Deliverable in hard-access anatomies Optimal visibility Reliable, predictable, and extremely precise placement No indication of foreshortening Radial strength sufficient for v. hard lesions Piotr LINC

50 . CGuard embolic prevention stent system Full respect of the carotid bifurcation anatomy -> endovascular anatomic reconstruction. Optimal performance across all lesion subsets (including high calcium/thrombus/string) Piotr LINC

51 CARENET Conclusions CARENET Trial demonstrated unprecedented safety of the CGuard stent, with 30-day MACCE rate of 0%. The CGuard device success and procedure success rate were 100%. Majority of patients treated with CGuard have zero ipsilateral lesions on post-procedural DWI.

52 CARENET Conclusions 10-fold reduction in average lesion volume when compared to conventional carotid stents. All but one peri-procedural lesion had resolved completely by 30 days. 6 month ultrasound analysis is indicative of normal stent healing without any restenosis concern and with normal ECA flow. CARENET data indicates that CGuard may offer unique clinical benefits for patients undergoing CAS with unprecedented safety.